MiniMed®630G MMT-1715KRecalls & reported problems

Summary

The FDA's MAUDE database contains 6,645 adverse event reports that list this exact device (DI 00763000090197), received between May 17, 2018 and Jun 25, 2025 — classified as 17 deaths, 1,508 injuries, 5,120 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1,793 reports).

2 FDA recall records name this device's identifier, 2 still open.

9 other recalls cover devices cleared under the same FDA submission (P150001); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 13, 2026Open, Classified

   All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

   Z-1748-2026 · Root cause: Device Design · FDA record ↗

2. Jul 31, 2024Open, Classified

   Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

   Z-0001-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 6,645 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED RAPID BATTERY DEPLETION, WITH MULTIPLE "LOW BATTERY" AND "REPLACE BATTERY NOW" ALERTS OCCURRING LESS THAN 8 HOURS APART, DESPITE USING NEW ENERGIZER ALKALINE BATTERIES. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED THAT INCLUDED REVIEWING ALARM HISTORY AND VERIFYING BATTERY USAGE, BUT THE ISSUE PERSISTED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325778 ↗
• MalfunctionJun 25, 2025Computer Software Problem; Battery Problem; Communication or Transmission Problem; Computer Software Problem; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED MULTIPLE ALARMS, INCLUDING PUMP ERROR 4 ALARM (THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM), PUMP ERROR 53 ALARM (SOFTWARE ERROR DETECTED) AND BATTERY FAILED ALARM, WITH THE BATTERY DEPLETING RAPIDLY (HALF DRAINED OVERNIGHT). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, INCLUDING CLEARING ALARMS, INSPECTING THE BATTERY CAP AND COMPARTMENT FOR DAMAGE OR CORROSION, AND REVIEWING PUMP SETTINGS. THE CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND CALL BACK IF THE ISSUE PERSISTED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325559 ↗
• MalfunctionMay 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER HAD DIFFERENT METER READINGS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED IN THE PRODUCT WAS MMT-1715K. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN IS REQUIRED FOR MMT-1715K.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307388 ↗
• InjuryJul 25, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 267 MG/DL AT THE TIME OF THE EVENT. CUSTOMER BELIEVES THAT THE PUMP WAS NOT GIVING ENOUGH INSULIN. THE CUSTOMER WAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTION AND THE CUSTOMER DOES NOT EXPERIENCED SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ALSO REPORTED HE EXPERIENCED A BLOOD GLUCOSE VALUE OF 433 MG/DL ON THE DAY OF HIGH BLOOD GLUCOSE EVENT REPORTED. THE CUSTOMER HAD USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE INSULIN PUMP HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 17387064 ↗
• MalfunctionAug 2, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD CRACKED RETAINER RING AND THE RESERVOIR WAS ABLE LOCK IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146250 ↗
• MalfunctionJul 28, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119523 ↗
• MalfunctionJul 26, 2022No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK BATTERY FROM TO BOTTOM AND RETAINER RING CAME OFF. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101567 ↗
• MalfunctionJul 21, 2022Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT NO DELIVERY/OCCLUSION ALARM DURING THERAPY OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073908 ↗
• MalfunctionJul 20, 2022Obstruction of Flow; Date/Time-Related Software Problem; Moisture or Humidity Problem; Obstruction of Flow; Date/Time-Related Software Problem; Moisture or Humidity Problem

  MEDTRONIC RECEIVED INFORMATION THAT OCCLUDED, NO DELIVERY/OCCLUSION ALARM - UNKNOWN TIMING, TIME/CLOCK ANOMALY, EXPOSED TO MOISTURE OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15063588 ↗
• MalfunctionJul 20, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15063572 ↗
• MalfunctionJul 18, 2022Break

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15044543 ↗
• MalfunctionJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BLOOD GLUCOSE VALUE WAS 243 MG/DL. SG VALUE WAS 56 MG/DL. SG AND BG DIFFERENCE WAS 187 MG/DL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 15040657 ↗
• DeathJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME ON (B)(6) 2020. THE CAUSE OF DEATH WAS ACUTE CORONARY/UNSTABLE ANGINA. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER RETURNED THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Angina

  MAUDE report 15039214 ↗
• MalfunctionJul 18, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED OCCURRED. THERE WAS AN ALLEGATION OF BLOOD LOSS, RASH AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rash

  MAUDE report 15038772 ↗
• DeathJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOSPITAL ON (B)(6) 2019. THE CUSTOMER WAS HOSPITALIZED ON(B)(6) 2019. THE CALLER MENTIONED THAT THE CUSTOMER WAS ADMITTED FOR LOW HEMOGLOBIN. THE CAUSE OF DEATH WAS COMPLICATION FROM CHEMO THERAPY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER LAST WORN THE INSULIN PUMP ON (B)(6) 2019. THE INSULIN PUMP WILL BE RETURNED FOR PRODUCT ANALYSIS.

  Patient problems: Anemia

  MAUDE report 15038282 ↗
• MalfunctionJul 15, 2022No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025509 ↗
• MalfunctionJul 13, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14998262 ↗
• MalfunctionJul 12, 2022Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR. THE CUSTOMER REPORTED THAT THEY RECEIVED A CRITICAL PUMP ERROR IMAGE ON THE PUMP SCREEN. CUSTOMER REPORTED THAT THEY HAD RECEIVED THE OPEN BOOK IMAGE ON THE PUMP SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED BACK FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988356 ↗
• MalfunctionJul 12, 2022Unexpected Therapeutic Results; Appropriate Device Problem Term/Code Not Available; Unexpected Therapeutic Results; Appropriate Device Problem Term/Code Not Available

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP AUTO SUSPEND INSULIN DELIVERY. THE CUSTOMER STATED THEY WERE GETTING AUTO SUSPEND ALERT AND NO BUTTONS WERE PRESSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984835 ↗
• MalfunctionJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER STATED THEY HAD LOW BLOOD GLUCOSE EVENT OF 57 MG/DL. PATIENT HAD TREATED WITH FOOD. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS OVER DELIVERING. INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 14984750 ↗
• MalfunctionJul 12, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP NEEDED TO PROGRAM. THE CUSTOMER DID THE TROUBLESHOOT AND ABLE TO PROGRAM THE INSULIN PUMP. THE CUSTOMER STATED THEY HAD HIGH BLOOD GLUCOSE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14984585 ↗
• MalfunctionJul 12, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BATTERY WAS TAKEN OUT FROM INSULIN PUMP AND IT DID NOT WENT OFF. THE CUSTOMER STATED THE CURRENT BLOOD GLUCOSE WAS 300 MG/DL AND WAS USING INSULIN PUMP FOR 24 HOURS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14984559 ↗
• MalfunctionJul 12, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984021 ↗
• MalfunctionJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED VIA MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE VALUE AT TIME OF INCIDENT WAS 312 MG/DL. CUSTOMER DID EXPERIENCE SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE SUCH AS NAUSEA, VOMITING, ABDOMINAL PAIN AND DIFFICULTY BREATHING. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE WAS 312 MG/DL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED. CUSTOMER DID NOT ALLEGE THAT THE INSULIN PUMP WAS UNDER DELIVERING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14983751 ↗
• MalfunctionJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED INSULIN FLOW BLOCK ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14983652 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150001. One submission often covers many models, so check the product and lot details in each record.

• Z-1740-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-0193-2023 · Sep 20, 2022 · Open, Classified
  Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
• Z-0855-2022 · Jan 27, 2022 · Open, Classified
  MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-18
• Z-0517-2021 · Apr 30, 2020 · Open, Classified
  MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rate
• Z-0955-2020 · Nov 21, 2019 · Open, Classified
  Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
• Z-0683-2019 · Oct 3, 2018 · Open, Classified
  Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
• Z-2603-2017 · May 8, 2017 · Terminated
  MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
• Z-2602-2017 · May 8, 2017 · Terminated
  MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.